FDA.reportPublic FDA data

Misoprostol

Product NDC
71335-0460
11-digit product format
713350460
Labeler code
71335
Product ID
71335-0460_fdafd2c5-8c12-4575-a707-bfa7a46cc03c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091667
Marketing category
ANDA
Marketing start
2012-07-25
Marketing end
0000-00-00
Substance
MISOPROSTOL
Active strength
200 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9Product name320231221
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0460-12024-01-30C16284748780-11030e365-2695-111a-e063-dadaa90a10e2Misoprostol Tablets Lupin Pharmaceuticals, Inc
71335-0460-22024-01-30C16284748780-11030e365-2695-111a-e063-dadaa90a10e2Misoprostol Tablets Lupin Pharmaceuticals, Inc
71335-0460-32024-01-30C16284748780-11030e365-2695-111a-e063-dadaa90a10e2Misoprostol Tablets Lupin Pharmaceuticals, Inc
71335-0460-42024-01-30C16284748780-11030e365-2695-111a-e063-dadaa90a10e2Misoprostol Tablets Lupin Pharmaceuticals, Inc
71335-0460-52024-01-30C16284748780-11030e365-2695-111a-e063-dadaa90a10e2Misoprostol Tablets Lupin Pharmaceuticals, Inc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0460-1Misoprostol30 in 1 BOTTLETABLET307
71335-0460-2Misoprostol60 in 1 BOTTLETABLET607
71335-0460-3Misoprostol28 in 1 BOTTLETABLET287
71335-0460-4Misoprostol1 in 1 BOTTLETABLET17
71335-0460-5Misoprostol8 in 1 BOTTLETABLET87

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0460MISOPROSTOL TABLET [BRYANT RANCH PREPACK]7Legacy NDC, 5 package rows20220129_fdafd2c5-8c12-4575-a707-bfa7a46cc03c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSNfdafd2c5-8c12-4575-a707-bfa7a46cc03c7
317128misoprostol 0.2 MG Oral TabletSCDfdafd2c5-8c12-4575-a707-bfa7a46cc03c7
317128misoprostol 200 MCG Oral TabletSYfdafd2c5-8c12-4575-a707-bfa7a46cc03c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0460-17133504600130 TABLET in 1 BOTTLE (71335-0460-1) 30 tablet2013-04-050000-00-00NoNoCurrent
71335-0460-27133504600260 TABLET in 1 BOTTLE (71335-0460-2) 60 tablet2013-04-050000-00-00NoNoCurrent
71335-0460-37133504600328 TABLET in 1 BOTTLE (71335-0460-3) 28 tablet2013-04-050000-00-00NoNoCurrent
71335-0460-4713350460041 TABLET in 1 BOTTLE (71335-0460-4) 1 tablet2013-04-050000-00-00NoNoCurrent
71335-0460-5713350460058 TABLET in 1 BOTTLE (71335-0460-5) 8 tablet2013-04-050000-00-00NoNoCurrent